FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,110 results
1849–1872 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 28, 2020
Jade
K201794 · LIT
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 28d
Cleared Jul 28, 2020
TRUSELECT Microcatheter
K201792 · KRA
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Jul 24, 2020
Tempus LS - Manual
K200849 · LDD
Remote Diagnostic Technologies, Ltd....
Cardiovascular · 115d
Cleared Jul 23, 2020
AVVIGO Guidance System
K201713 · DQK
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Jul 23, 2020
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K200738 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 122d
Cleared Jul 22, 2020
Reprocessed BRK Transseptal Needle
K192998 · NMK
Innovative Health, LLC
Cardiovascular · 268d
Cleared Jul 16, 2020
Arm Blood Pressure Monitor
K193456 · DXN
Ningbo Ranor Medical Science &...
Cardiovascular · 216d
Cleared Jul 15, 2020
LifeSignals ECG Remote Monitoring Patch Platform
K200690 · DRG
Lifesignals, Inc.
Cardiovascular · 121d
Cleared Jul 12, 2020
AGE Automatic Wrist Blood Pressure Monitor
K193628 · DXN
Dongguan E-Test Technology Co., Ltd.
Cardiovascular · 199d
Cleared Jul 12, 2020
Automatic Upper Arm Blood Pressure Monitor
K193627 · DXN
Dongguan E-Test Technology Co., Ltd.
Cardiovascular · 199d
Cleared Jul 10, 2020
HD Steth
K201299 · DQD
Hd Medical, Inc.
Cardiovascular · 56d
Cleared Jul 10, 2020
SmartLinx Vitals Plus Patient Monitoring System
K200856 · MWI
Capsule Technologie Sas
Cardiovascular · 100d
Cleared Jul 10, 2020
B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System
K200568 · JOW
B&J Manufacturing , Ltd.
Cardiovascular · 128d
Cleared Jul 10, 2020
Automatic Upper Arm Blood Pressure Monitor
K193624 · DXN
Dongguan E-Test Technology Co., Ltd.
Cardiovascular · 197d
Cleared Jul 08, 2020
CAPERE Thrombectomy System
K201216 · QEW
Vascular Medcure, Inc.
Cardiovascular · 64d
Cleared Jul 08, 2020
Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch
K200955 · DXZ
Vascutek, Ltd.
Cardiovascular · 90d
Cleared Jul 08, 2020
B&J DVT Compression Devices MHH800/MHH800SQ
K200154 · JOW
B&J Manufacturing , Ltd.
Cardiovascular · 168d
Cleared Jul 03, 2020
LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command...
K200795 · MXD
Medtronic, Inc.
Cardiovascular · 99d
Cleared Jul 02, 2020
AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable...
K200674 · DSA
Atrility Medical, LLC
Cardiovascular · 108d
Cleared Jul 02, 2020
VenaOne
K200285 · JOW
Vena Group, LLC
Cardiovascular · 148d
Cleared Jul 02, 2020
Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer
K193259 · DXQ
Little Doctor Electronic...
Cardiovascular · 219d
Cleared Jul 01, 2020
SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band,...
K201449 · KRH
Medtronic, Inc.
Cardiovascular · 30d
Cleared Jun 30, 2020
LassoStar Circular Mapping Catheter
K193632 · DRF
Biosense Webster, Inc.
Cardiovascular · 186d
Cleared Jun 29, 2020
Twin-Pass Dual Access Catheter
K193119 · DQY
Vascular Solutions, LLC
Cardiovascular · 230d